|
Device | ABBOTT REALTIME HCV GENOTYPE II |
Generic Name | Assay, genotyping, hepatitis c virus |
Regulation Number | 866.3170 |
Applicant | ABBOTT MOLECULAR 1300 EAST TOUHY AVENUE DES PLAINES, IL 60018 |
PMA Number | P120012 |
Supplement Number | S009 |
Date Received | 07/29/2015 |
Decision Date | 10/09/2015 |
Reclassified Date
|
12/22/2021 |
Product Code |
OBF |
Advisory Committee |
Microbiology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR TWO CHANGES TO THE APPLICATION SPECIFICATION FILES TO EXTEND THE CHILLER DELAY TIMER AND CHANGE THE CONDUCTIVITY SETTING FOR THE DETECTION OF RNA WASH2 LIQUID. |